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Completed

NCT Number: NCT00315926

Melatonin and Cardiac Outcome After Major Surgery

The purpose of this study is to assess whether treatment with melatonin can reduce cell damage and inflammatory stress response and thereby occurrence of myocardial injury after abdominal aortic surgery.

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Key information

Conditions

Aortic Aneurysm Aneurysm Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte

Hellerup, Denmark

About this study

Abdominal aortic surgery is associated with a significant increase of oxidative and inflammatory stress response. Aortic surgery is also associated with elevated troponin which is a sensitive and specific marker for myocardial injury. The severity of oxidative stress is correlated with elevated troponin. Melatonin, which is a hormone produced in brain, seems to modify cell damage and inflammation. On the other hand we know, that melatonin production first night after surgery is disturbed. The purpose of this study is therefore to determine whether treatment with melatonin can reduce cell damage and inflammation, and thereby occurrence of myocardial injury associated with abdominal aortic surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Indication for elective abdominal aortic aneurism surgery or periphery atheroscleroses with indicated protheses operation
  • Patients between 18 and 80 years old

Exclusion criteria

  • Patients with ASA class > 3
  • Anticoagulation therapy (marevan and marcoumar)
  • Preoperative therapy with opioid, anxiolytic and hypnotic medication
  • Renal insufficient (preoperative creatinin > 200 mmol/l)
  • Well-known liver insufficient
  • Alcohol consumption (more than 5 drinks)
  • Compliance (language difficulty, mental problems etc.)
  • Pregnancy and breast-feeding
  • Lack of written consent

Treatment and study plan

Melatonin

Drug

Melatonin 50 mg during surgery and 10 mg every night for 3 nights

Placebo

Drug

a mixture of ethanol and physiological saline

Primary outcomes

  1. Cardiac morbidity

    Time frame: 30 days

    artrial fibrillation, unstable angina, myocardial infarction, ECG changes (T-wave inversion for more than 24 hours, new ST-segment depression for more than 24 hours, acute ST-segment elevation with appearance of q-waves or loss of R-waves, left bundle branch block), or a characteristic pattern of rising and falling values of troponin-I, or pulmonary oedema. Mortality was defined as any cause of death in the 30 days after surgery.

Secondary outcomes

  1. Oxidative and inflammatory stress response

    Time frame: 3 days

    Blood samples for analysis of malondialdehyde (MDA), ascorbic acid (AA), dehydroascorbic acid (DHA) and C-reactive protein (CRP) assessed before and after operation

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

Melatonin and Cardiac Morbidity After Elective Abdominal Aortic Aneurism Repair

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 19, 2006
Registry last updated
Jun 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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